CN1737566B - Analytical test strip with control zone - Google Patents
Analytical test strip with control zone Download PDFInfo
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- CN1737566B CN1737566B CN2005100980570A CN200510098057A CN1737566B CN 1737566 B CN1737566 B CN 1737566B CN 2005100980570 A CN2005100980570 A CN 2005100980570A CN 200510098057 A CN200510098057 A CN 200510098057A CN 1737566 B CN1737566 B CN 1737566B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
- Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
- Y10T436/143333—Saccharide [e.g., DNA, etc.]
- Y10T436/144444—Glucose
Abstract
An analytical test strip for the determination of an analyte (e.g., glucose) in a liquid sample (such as whole blood) includes a matrix, with the matrix having a sample detection zone and a control zone(s). The sample detection zone includes a first reagent composition that reacts with analyte in the liquid sample to create a sample response and is configured to receive a first portion of the liquid sample. The control zone(s) includes a second reagent composition and is configured to receive another portion(s) of the liquid sample. In addition, the second reagent composition creates a predetermined control response when exposed to the second portion of the liquid sample. The predetermined control response, either alone or in combination with the sample response, can be employed to verify acceptable functioning of the analytical test strip and/or to provide a calibration factor for the analytical test strip.
Description
Technical field
The present invention summarizes and relates to analytical equipment, is specifically related to analytical test strip.
Background technology
The multiple conventional analysis test-strips of measuring analyte in the fluid sample is known.The analytical test strip of for example measuring glucose in (for example detecting and/or measurement of concetration) whole blood sample is extensive use of (referring to for example US5,304,468) by patient and their health care provider.
Usually, the conventional analysis test-strips is used with the associating meter of detection optical response (for example than colour response) or electrochemical response, described response be by analyte and be present in the analytical test strip or on reagent composition between interaction and on analytical test strip, produce.Unfortunately, the normal function of this analytical test strip and associating meter thereof is subjected to the influence of various unfavorable disturbing factors.For example, the reagent composition of analytical test strip can be degraded in a period of time, causes the function of analytical test strip undesired.Similarly, the part of functions mistake of meter or meter have used wrong calibration code.In addition, the character of fluid sample self or composition also can cause the unfavorable interference to the normal function of analytical test strip and/or associating meter.This unfavorable interference from fluid sample self is called " matrix effect ".
In order to verify the normal function of a collection of test-strips and associating meter, the user usually checks a analytical test strip in a collection of with the contrast solution that contains the scheduled volume analyte.Yet, the not only time-consuming trouble of this inspection, and waste, because the analytical test strip that is used to check must abandon.In addition, the contrast solution that is used for this inspection can not be simulated reliably or the matrix effect of the actual liquid sample that the forecast analysis test-strips is used.
Therefore, this area still needs to verify in rapid and simple mode the analytical test strip of its normal function.In addition, this checking should be considered the matrix effect of the fluid sample that analytical test strip is used.
Summary of the invention
Embodiment of the present invention comprise the analytical test strip that can verify its normal function in rapid and simple mode.In addition, the matrix effect of fluid sample has been considered in this checking.
The analytical test strip of measuring analyte (for example glucose) in the fluid sample (as whole blood) according to exemplary of the present invention comprises matrix, and described matrix has sample detection district and check plot.The sample detection district comprise with fluid sample in analyte response producing first reagent composition of detectable sample response, and be configured to accept the first of fluid sample.The check plot comprises second reagent composition, and is configured to accept the fluid sample second portion.In addition, when being exposed to the second portion of fluid sample, the detectable predetermined contrast response of the second agent combination deposits yields.Can use predetermined contrast response separately, or be used in combination,, or provide the calibration factor of analytical test strip with the normal function of check analysis test-strips and/or associating meter with sample response.
Because when being applied to single liquid sample (for example patients'blood sample), analytical test strip produces sample response and predetermined contrast response according to embodiments of the present invention, so eliminated time, work and the cost of using independent contrast solution related.In addition, because the sample detection district of analytical test strip of the present invention and check plot are exposed to the part separately of same fluid sample, so the effect of fluid sample (i.e. " matrix " effect) all exists in sample detection district and check plot, and therefore sample response and predetermined contrast response all there is contribution.And, because sample detection district and check plot are integrated on the single analytical test strip, so can avoid only for verifying purpose operational analysis test-strips and the cost of following thereof.
Description of drawings
By following detailed description part and the accompanying drawing that has provided the illustrative embodiment of using the principle of the invention of reference, the feature and advantage that can better understand the present invention:
Fig. 1 is the simplification decomposition diagram according to the analytical test strip of illustrative embodiments of the invention.
Fig. 2 is that the simplification perspective based on the method for netting of making the analytical test strip of the various embodiments according to the present invention is described.
Fig. 3 is the ideal diagram of analyte concentration in the fluid sample (x axle) to response (sample response or predetermined contrast response) (y axle).
Fig. 4 is the simplification decomposition diagram of the analytical test strip of another exemplary according to the present invention.
Fig. 5 A and 5B are respectively K/S to the curve of the scanning distance of the analysis bar of embodiment 1 and K/S to the sample detection district, the curve of the concentration of glucose of check plot and both differences; With
Fig. 6 A and 6B are respectively K/S to the curve of the scanning distance of the analysis bar of embodiment 2 and K/S to the sample detection district, the curve of the concentration of glucose of check plot.
Embodiment
Fig. 1 is a simplification decomposition diagram of measuring the analytical test strip 100 of analyte (being glucose) in the fluid sample (being whole blood) according to illustrative embodiments of the invention.Though analytical test strip 100 is applicable to the glucose of measuring in the whole blood, in case reported the present invention, the embodiment that one skilled in the art will know that analytical test strip of the present invention is applicable to the analyte of measuring in other analyte (as calcium, ketone, medicine etc.) and/or other fluid sample (for example urine sample, blood serum sample, plasma sample, interstitial fluid sample etc.).
Pressure-sensitive adhesive layer 106 can be the pressure-sensitive adhesive layer of the known any appropriate of one of ordinary skill in the art.Basalis 108 comprises hole 108b, exposes matrix 104 and can detect sample response and the predetermined contrast response that produces on matrix 104 by this hole.
First reagent composition that is included in sample detection district 104a can be first reagent composition that is fit to arbitrarily well known by persons skilled in the art.When target analytes is glucose and fluid sample when being the situation of whole blood sample, suitable reagent includes but not limited to tetrazolium dye, electron transfer agents (as the azophenlyene Methylsulfate) and enzyme.Following embodiment 1 and 2, and for example US 4,935,346,5,304,468,6,162,397 and 6,168,957 also describes suitable reagent in detail, every piece of document all is hereby incorporated by in full.In addition, in case reported the present invention, the component that one skilled in the art will know that first reagent composition that the sample detection district of analytical test strip of the present invention is used depends on the analyte that detected and the characteristic of fluid sample, and the mode that will use of test sample response.
Sample response and predetermined contrast response are also referred to as " detectable " response sometimes, will be detected by the meter related with analytical test strip or other device because can reckon with these responses.For colorimetric sample response and predetermined contrast response, this meter comprises light source (as light emitting diode [LED]), photodetector and can detect the suitable Circuits System of also analytic sample response and predetermined contrast response.In case reported the present invention, those skilled in the art can improve conventional meter easily to carry out this function.
Second reagent composition that is included in check plot 104b can utilize, for example with the identical conventional chemical material (for example identical dyestuff, enzyme, damping fluid etc.) of first reagent composition among the sample detection district 104a.Yet second reagent composition also comprises the reagent component of additional reagent component and/or improvement ratio usually, makes when second reagent composition is exposed to the second portion of fluid sample, produces predetermined contrast response.
Technology by known any appropriate forms sample detection district 104a and check plot 104b on matrix 104.For example, Fig. 2 has described the technology based on net on the reagent paint matrix 104.In the described technology based on net of Fig. 2, matrix 104 is in advance with the impregnated film of the co-reagent component of sample detection district 104a and check plot 104b (for example enzyme and buffering reagent component).When the matrix 104 of pre-soaked mistake is mobile along " net direction " shown in Fig. 2, with groove shape dispense tip 200 and nozzle 200a and 200b with on the extra reagent component paint matrix 104.For example, can apply dye solution to form sample detection district 104a, apply dyestuff and glucose solution to form check plot 104b by nozzle 200b simultaneously by nozzle 200a.In this situation, use the enzyme of dye solution and pre-soaked usefulness and cushion reagent to form first reagent composition, the enzyme of use dyestuff and glucose solution and pre-soaked usefulness and buffering reagent are to form second reagent composition.
Again with reference to figure 1, the predetermined contrast response of check plot 104b can be (i) predetermined response to stronger than sample response for example; (ii) than the predetermined response to a little less than the sample response; Or (iii) do not rely on the predetermined response to of analyte concentration in the fluid sample.
In order to obtain to compare according to the strong predetermined response to of response, second reagent composition can be first reagent composition (or its component) and be used for and the response in the sample detection district specific energy combination that improves the auxiliary reagent component that (promptly increasing) check plot responds mutually.This " interpolation " auxiliary reagent component can be, for example analyte.For example, if the target analytes in the fluid sample is a glucose, second reagent composition can be to comprise the component of first reagent composition and the combination of glucose, and wherein the amount of glucose can produce the required predetermined contrast response that is better than sample response.The following examples 1 have comprised the example of second reagent composition that comprises " interpolation " auxiliary reagent component.
On the other hand, in order to obtain to compare according to the weak predetermined response to of response, second reagent composition can be for example first reagent composition (or its component) and per sample detection zone sample response and reduce the combination of the auxiliary reagent component that (promptly deducting) check plot responds.This " deducting " auxiliary reagent component can be for example with (i) analyte, the (ii) component of second reagent composition or (iii) produce to stop or alleviate the interactional reagent component of intermediate product (as hydrogen peroxide) in the response hierarchy of predetermined contrast response of check plot response.At analyte is in the situation of glucose and the oxidase colorimetric reagent composition that uses the hydrogen peroxide connection, can use ascorbic acid or other reductibility compound as " deducting " auxiliary reagent component.
Because second reagent composition of check plot can be that for example combination of first reagent composition in sample detection district and auxiliary reagent component is so the common any agent component in sample area and check plot can be present in whole matrix 104.
At last, in order to obtain not rely on the predetermined contrast response of analyte concentration in the fluid sample, second reagent composition can, for example comprise each component of first reagent composition, comprise dyestuff and analyte.Yet, dyestuff in second reagent composition exists with the response limits amount, make when second reagent composition is exposed to the second portion of fluid sample, the analyte that exists in second reagent composition be enough to second reagent composition in whole substantially dyestuff reaction respond to produce predetermined contrast.Therefore, because the generation of predetermined contrast response is the dyestuff that exists in second reagent composition and the result of analyte basically, so predetermined contrast response does not rely on the analyte in the fluid sample.On the contrary, predetermined contrast response depends on the amount of the dyestuff that exists in second reagent composition.This second reagent composition is also referred to as " dyestuff is restricted " reagent composition, because when having unnecessary analyte, and the predetermined contrast response of the amount of dyestuff decision.The following examples 2 provide the example of restricted second reagent composition of this dyestuff.
Fig. 3 is for the representative analysis of the present invention bar, analyte concentration in the fluid sample (mg/L) (x axle) is with respect to the ideal diagram of response (sample response or predetermined contrast response) (y axle), wherein second reagent composition is the combination of first reagent composition and " interpolation " auxiliary reagent component (for example, the analyte that measure).Solid line (line A) representative hypothesis does not exist disturbing factor (as the reagent component of degrading in first and/or second reagent composition for example, or the matrix effect of fluid sample) time, the expection relation between analyte concentration and the response (sample response or predetermined contrast response).When there is the situation of the disturbing factor that reduces sample response and predetermined contrast response in dotted line (line B) representative, the relation between observed in theory analyte concentration and the response.
Suppose that the analyte concentration in the fluid sample is " C ", the sample response of expection is " D ".The predetermined contrast response of supposing the same fluid sample again is " E " (corresponding analyte concentration is " F ").This predetermined contrast response can by for example comprise with " F " and " C " between second reagent composition of difference equivalence in the analyte generation.Yet viewed sample response is " G " among Fig. 3, and viewed predetermined contrast response is " H ".Difference between the sample response of expection and the predetermined contrast response is the difference (being the vertical arrows that is designated as " expection difference " among Fig. 3) between " D " and " E ", and viewed difference is the difference (being the vertical arrows that is designated as " observation difference " among Fig. 3) between " G " and " H ".
In the situation of Fig. 3, can utilize comparative observation difference and expection difference to determine to detect the analytical test strip of these responses and/or whether unite the meter function normal.In this comparison, will know the expection difference in advance according to first and second reagent compositions.If for example, observed difference equates with the expection difference in predetermined tolerance, can think that the function of analytical test strip and associating meter is normal.Yet,, can think that the function of analytical test strip and/or associating meter is unreliable if observed difference is unequal with the expection difference in predetermined tolerance.By this way, (i.e. " on the plate ") indicator signal on the bar of the reliability that detects as the operational analysis test-strips of check plot.
Perhaps, can utilize expection difference and observed difference to adjust sample response, thereby by using for example following algorithm computation to disturb:
ASP＝SR(1+((ED-OD)/ED))
Wherein:
ASP is the sample response of adjusting;
SR is a sample response;
ED is the expection difference; With
OD is observed difference.
In algorithm, (1+ ((ED-OD)/ED)) is basically as the calibration factor of analytical test strip for the factor.
In case reported the present invention, one skilled in the art will know that second reagent composition that use to produce than the predetermined contrast response a little less than the sample response also can obtain to be used for evaluation analysis test-strips and/or associating meter function and whether expect difference and observe difference normally.Do not rely in the situation of the predetermined contrast response of analyte in the fluid sample in the second agent combination deposits yields, observed contrast response can with the predetermined contrast response ratio of expection, as analytical test strip and/or associating meter function normal measure whether.
The measurement of sample response and predetermined contrast response, the comparison of the response difference of the calculating of observed response difference and observed response difference and expection can be undertaken by the device that uses any appropriate well known by persons skilled in the art.For example, can use portable meter well known by persons skilled in the art and microprocessor and/or logical circuit to finish this measurement and comparison.
Analytical test strip commonly used and associating meter thereof have the dynamic range (promptly surpass this scope, the increase of analyte concentration makes the proportional increase of sample response) of appointment.Therefore, can imagine when fluid sample has high relatively analyte concentration, use second reagent composition and " interpolation " auxiliary reagent component will cause surpassing the predetermined contrast response of the dynamic range upper limit.Also can imagine when fluid sample has low relatively analyte concentration, use second reagent composition and " deducting " auxiliary reagent component will cause being lower than the predetermined contrast response of dynamic range lower limit (being typically zero).The auxiliary reagent component maximization of wishing to make the auxiliary reagent composition of interpolation or deducting can also maximize signal-noise (S/N) ratio in the process of comparative sample response and predetermined contrast response because do like this.Yet auxiliary reagent component maximization interpolation or that deduct also will have increased access to the possibility of the predetermined contrast response that exceeds dynamic range.
In order to proofread and correct the consequence that this dynamic range causes, the embodiment of analytical test strip of the present invention can comprise and has the sample detection district, the matrix of first check plot and second check plot.The sample detection district comprise with fluid sample in analyte response produce first reagent composition of sample response, and be configured to accept the first of fluid sample.First check plot comprises second reagent composition and is configured to accept first fraction in the second portion of fluid sample, and second check plot comprises the 3rd reagent composition and is configured to accept second fraction in the second portion of fluid sample.
In this embodiment, second reagent composition and the reaction of described first fraction produce the first predetermined contrast response, and the 3rd reagent composition and the reaction of described second fraction produce the second predetermined contrast response.In addition, the first predetermined contrast response is different from the second predetermined contrast response.
If second reagent composition comprises " interpolation " auxiliary reagent component and the 3rd reagent composition and comprises " deducting " auxiliary reagent component that the first predetermined contrast response and the second predetermined contrast response are mutually the same so.In addition, at least the first predetermined contrast response and the second predetermined contrast response one of them in dynamic range, be high relatively or low relatively regardless of the analyte concentration in the fluid sample.
Fig. 4 is the simplification decomposition diagram that another exemplary according to the present invention is measured the analytical test strip 300 of analyte (being glucose) in the fluid sample (being whole blood).Analytical test strip 300 comprise fluid sample sprawl the layer 302, matrix 304, pressure-sensitive adhesive layer 306 and basalis 308.In the description of Fig. 4, show that pressure-sensitive adhesive layer 306 sticks on the basalis 308.
The matrix 304 of analytical test strip 300 comprises rete 310 and barrier layer 312.In addition, matrix 304 comprise have with fluid sample in analyte response produce the sample detection district 304a of first reagent composition of the detectable sample response (for example than colour response) depend on analyte concentration in the fluid sample.Sample detection district 304a is configured to accept to be applied to the first that fluid sample is sprawled the fluid sample of floor 302, and comprises the part of rete 310 and the part of barrier layer 312.
Matrix 304 also comprises having works as the check plot 304b that the second portion that is exposed to fluid sample produces second reagent composition of detectable predetermined contrast response (for example Yu Ding ratio colour response).Check plot 304b is configured to accept to be applied to the second portion that fluid sample is sprawled the fluid sample of layer 302.
Should be noted that before operational analysis test-strips 300 component of first and second reagent compositions just can be present on the rete 310 or on the barrier layer 312.When fluid sample when fluid sample is sprawled layer 302 and is passed through barrier layer 312 and transfer to rete 310, first and second reagent component that are present in barrier layer 312 just are dissolved in the fluid sample and transfer to rete 310.
Fluid sample is sprawled layer 302 and is used for fluid sample is spread into whole matrix 304, makes the first of fluid sample transfer to sample detection district 304a, and the second portion of fluid sample is transferred to check plot 304b.
Embodiment
The analytical test strip that is used for measuring whole blood sample glucose with following formulations prepared from solutions:
Solution A (be also referred to as " enzyme, buffering agent and stabiliser solution)
10ml water
112.8mg citric acid, monohydrate
139.2mg sodium citrate, dehydrate
100mg sweet mellow wine
8.4mgEDTA disodium
45mg?GantrezS95
168.3mg?Crotien?SPA
The 1100IU glucose oxidase
The 617IU horseradish peroxidase
(0.5ml being suspended in the 11%w/v Carbopol 910 of acetonitrile)
(1.5ml 0.1M citrate, pH 5.0)
Solution B 1 (being also referred to as " dye solution ")
10ml (52.5: 17.5: 30 ethanol: methyl alcohol: water)
A 40.9mg N-[sulfonyl-benzene sulfonic acid sodium salt]-3-methyl-2-[4-morpholinodithio quinoline ketone hydrazone (MBTH-SBS)
56.6mg 8-anilino-1-naphthalene sulfonic acid ammonium salt (ANS)
0.48ml (52.5: 17.5: 30 ethanol: methyl alcohol: the 20%w/v Maphos 60A in the water)
Solution C 1 (being also referred to as " dyestuff and glucose solution ")
10ml methyl alcohol
36.8mg?MBTH-SBS
60.8mgANS
The 32mg beta-d-glucose-
In order to prepare analytical test strip, by following method solution A is coated in (i.e. the asymmetric BTS30 polysulfone membrane of buying from US Filter) on the matrix: matrix eurypyloue one faces down, and matrix is made the matrix absorption solution A by the groove that contains solution A.Matrix is removed excessive solution A by the scraping bar.Allow then this matrix in the pressure air exsiccator at 79 ℃ of dry about 3min.
The dispense tip that use has a passage is drawn striped by groove shape mould (slot die) method with solution C on these fragments of 1/4 inch, the passage of described dispense tip enters on the direction vertical with matrix length at interval in 0.005 inch wide nozzle of 0.060 inch fluid.In order to prepare the analytical test strip of this embodiment, only use a nozzle.Nozzle upwards, the eurypyloue one side of matrix upwards hauls matrix with the speed of 5.5ft/min and passes through dispense tip.By syringe pump solution C 1 is transported to dispense tip, uses the heating gun dry matrices simultaneously with 0.8 μ l/min operation.After the drying, matrix is off-white color, does not have other visible color.
Should be noted that solution A, the combination of B1 and C1 is as second reagent composition that produces the predetermined contrast response of colorimetric when being exposed to blood sample.Because before blood sample is applied to analytical test strip, the reaction between glucose in the necessary prevention solution C 1 and the component of solution A and B1 is so use sweet mellow wine (it does not activate the enzyme that exists in the dry solution A) rather than water in the solution C 1.
After the drying, 1/4 inch * 1/4 inch substrate tablet stuck-at-/4 are inch wide, 0.014 inch thick, as basalis and have on Melinex 329 films of opening.Then 1 inch * 1/4 inch porous materials film (promptly from Porex, the porous polyethylene material that Fairburn GA obtains) is placed on and sprawls layer as fluid sample on the film and stick on the basalis with double-sided adhesive layer.The analytical test strip that obtains has the strip check plot vertical with the longitudinal axis of this analytical test strip.
With the whole blood (hematocrit 42%) of the equal portions test analytical test strip of preparation as mentioned above, described whole blood is adjusted to and contains 51,81 and 191mg/dl glucose by adding concentrated moisture d-glucose.Whole blood sample is placed directly in fluid sample above the matrix to be sprawled and carries out above-mentioned test on the layer.Whole blood sample is transferred in the matrix, and unnecessary whole blood sample is absorbed into fluid sample and sprawls in the layer.
After the reaction in 45 seconds, analytical test strip is inserted measurement mechanism.Measurement mechanism comprises based on reflectometer that can commercial Agilent HEDS 1500 bar code wands that obtain.Measurement mechanism comprise be used for LED/ photodetector that (i) operate in bar code wand to the circuit that (ii) the detecting device output valve is sent to PC via the A/D conversion.Measurement mechanism also comprises the stationary installation of analytical test strip to become 15 degree angles to arrange with bar code wand, makes that the focus of the plane of analytical test strip matrix and bar code wand is overlapping.
When each analytical test strip inserts stationary installation, the bottom surface of the matrix of bar code wand scanning analysis test-strips (being aperture).When doing like this, therefore bar code wand scanning matrix (opening by basalis exposes) also scan the sample area and the check plot of matrix.Ratio by the detecting device output valve calculating the detecting device output valve and obtain from the analytical test strip basalis changes into relative reflectance (R) with the detecting device output valve.Convert reflectance (R) to the K/S proportional amount of light absorption component of scattering medium (known in the art with) according to following relation then:
K/S＝(1-R)
2/2R
When analytical test strip passed through the detecting device of measurement mechanism, the measurement mechanism record was to the optical scanning of analytical test strip.Scan-data converts K/S as mentioned above to.Fig. 5 A described 51,81 and three glucose levels of 191mg/dl to the scanning of each analytical test strip.Among Fig. 5 A, the response of each side of middle crest is the sample response (being the sample detection district of each side of strip check plot) that produces in the sample detection district of analytical test strip.Among Fig. 5 A, the check plot responds between the response of sample detection district, and is to produce by the part that second reagent composition (combination of ie in solution A, B1 and C1) is exposed to whole blood sample.Fig. 5 B (graph of a relation of the K/S of sample detection district, check plot and both differences and concentration of glucose) proves that the difference of predetermined contrast response (representing with K/S) and sample response (also representing with K/S) substantially all is a steady state value at each glucose level of being tested.
The analytical test strip that is used for measuring whole blood sample glucose with following formulations prepared from solutions:
Solution A (be also referred to as " enzyme, damping fluid and stabiliser solution)
The composition of the solution A of embodiment 2 is identical with the solution A of embodiment 1.
Solution B 2 (being also referred to as dye solution B2)
10ml (52.5: 17.5: 30 ethanol: methyl alcohol: water)
174.6mg?MBTH-SBS
271mg(ANS)
Solution C 2 (being also referred to as " dyestuff and glucose solution C2 ")
10ml ethanol
The 300mg beta-d-glucose-
23.3mg?MBTH-SBS
39.7mgANS
In order to prepare the analytical test strip of this embodiment, solution A is coated on the BTS-30 film (being matrix) in the mode that solution application A is identical in the foregoing description 1.In the identical mode of solution C among the embodiment 11, draw striped with solution B 2 and C2 in the one side of matrix macropore, just solution B 2 and C2 draw a striped by 0.060 inch nozzle at interval simultaneously.Draw striped and be speed with 5.5ft/min, the turnover rate of 1.0 μ l/ seconds, 95 ℃ are carried out.Same way as with embodiment 1 further prepares analytical test strip then.This preparation method causes matrix to comprise comprising by the sample detection district of first reagent of solution A and B2 preparation and comprises by solution A, the check plot of second reagent composition of B2 and C2 preparation.
The combination that should be noted that solution A and solution B 2 as with blood sample in glucose response produce first reagent composition of colorimetric sample response.The example of the oxidase colorimetric reagent composition that those skilled in the art will be connected the combination of solution A and solution B 2 as hydrogen peroxide.
Test the analytical test strip of preparation as mentioned above with the adjusted equal portions whole blood of concentration of glucose (hematocrit levels is 42%) subsequently to 54mg/dl and 363mg/dl.Test is carried out as described in above-mentioned embodiment 1.Fig. 6 A and 6B have described the scanning result in the check plot and the sample detection district of the analytical test strip of accepting the whole blood equal portions.Though the response in sample detection district depends on the concentration of glucose in the whole blood equal portions, the predetermined contrast of check plot response is steady state value substantially and does not rely on concentration of glucose in the whole blood equal portions.
In case reported the present invention, one skilled in the art will know that analytical test strip of the present invention can be, for example based on the anode electrochemistry analysis test-strips.In this case, sample response and predetermined contrast response will be electrochemical responses.
Can imagine that utilization judges from predetermined contrast response and sample response that analytical test strip of the present invention obtains whether sample area and/or check plot have fully filled fluid sample.This mensuration can be passed through, and for example will be scheduled to contrast observation difference between response and the sample response and compare with the expection difference and carry out.
In addition, (i) clear area (promptly demonstrate and be equivalent to the zone that analyte concentration in the fluid sample is " blank " response of zero) makes it possible to measure response slope and responds intercept with combining of the check plot of (ii) using the auxiliary reagent component of adding in second reagent composition.This mensuration is based on blank response and predetermined contrast response.Response slope and response intercept can be used for obtaining the calibration factor of analytical test strip subsequently and/or verify that integrated unit (for example meter) has used the correct calibration code.
Thereby the example of analytical test strip of the present invention can be used for the multiple analytes of analyzing liquid sample by using a plurality of sample areas and a plurality of relevant check plot configurations.When being exposed to fluid sample, the reagent composition of each sample area is suitable for taking place the response of specific analyte (for example glucose or ketone), and the reagent composition of relevant check plot will be suitable for taking place predetermined contrast response.In this situation,, so just can simplify the preparation process of analytical test strip if allow a plurality of sample areas be present on the matrix of whole analytical test strip with the common any agent component of a plurality of relevant sample areas.
The embodiment of analytical test strip of the present invention also can comprise the reference district that is not exposed to fluid sample.This reference district can be used for for example providing the standard reflection response, even after fluid sample is applied to analytical test strip.In addition, can provide and transform the white portion of accepting the partially liq sample, make the response of white portion can be used for estimating the characteristic of fluid sample (for example, the hematocrit of evaluating blood sample).
The embodiment of analytical test strip of the present invention can be configured to the response separately with linear mode scanning samples district and check plot, and signal processing technology (for example peak detection signal treatment technology) test sample district and check plot by being fit to.This linear sweep also can reduce required record between analytical test strip and the associating meter, and the recording to be beneficial to of this minimizing minimizes the volume of the required fluid sample of operational analysis test-strips.
Be to be understood that and use the various replacement schemes of invention embodiment as herein described to realize the present invention.Following claim has been determined scope of invention, and has therefore contained structure and equivalent thereof in these claim scopes.
Claims (7)
1. analytical test strip of measuring analyte in the fluid sample and using with the associating meter, described analytical test strip comprises:
Matrix, described matrix comprises:
Film;
Barrier layer;
In a part of film and barrier layer have with fluid sample in analyte response produce the sample detection district of first reagent composition of the colorimetric sample response depend on analyte concentration in the fluid sample, described sample detection district is configured to accept the first of fluid sample; With
At least one check plot that has second reagent composition in another part film and barrier layer, described at least one check plot is configured to accept the second portion of fluid sample,
Wherein when being exposed to the second portion of fluid sample, the predetermined colorimetric contrast of the second agent combination deposits yields responds;
Wherein there are the different of expection in the colorimetric sample response with the colorimetric contrast response of being scheduled to;
Wherein this expection is not both the normally functioning indication of analytical test strip;
Wherein the colorimetric sample response is detected by the associating meter with the colorimetric contrast response of being scheduled to.
2. the described analytical test strip of claim 1, wherein second reagent composition is to comprise the component of first reagent composition and the combination of analyte.
3. the described analytical test strip of claim 1, wherein second reagent composition comprises the auxiliary reagent component of interpolation.
4. the described analytical test strip of claim 3, wherein analyte is that the auxiliary reagent component of glucose and interpolation is a glucose.
5. the described analytical test strip of claim 1, wherein second reagent composition comprises the auxiliary reagent component that deducts.
6. the described analytical test strip of claim 5, wherein analyte is that glucose and the auxiliary reagent component that deducts are ascorbic acid.
7. the described analytical test strip of claim 6, wherein first reagent composition is the oxidase colorimetric reagent composition that hydrogen peroxide is connected with second reagent composition.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/903,108 US20060024835A1 (en) | 2004-07-30 | 2004-07-30 | Analytical test strip with control zone |
| US10/903108 | 2004-07-30 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1737566A CN1737566A (en) | 2006-02-22 |
| CN1737566B true CN1737566B (en) | 2010-05-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2005100980570A Expired - Fee Related CN1737566B (en) | 2004-07-30 | 2005-07-29 | Analytical test strip with control zone |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20060024835A1 (en) |
| EP (1) | EP1621887B1 (en) |
| JP (1) | JP2006071630A (en) |
| KR (1) | KR20060048959A (en) |
| CN (1) | CN1737566B (en) |
| AT (1) | ATE441864T1 (en) |
| AU (1) | AU2005203298A1 (en) |
| CA (1) | CA2514313A1 (en) |
| DE (1) | DE602005016347D1 (en) |
| ES (1) | ES2330759T3 (en) |
| HK (1) | HK1086335A1 (en) |
| IL (1) | IL169893A0 (en) |
| SG (1) | SG119334A1 (en) |
| TW (1) | TW200617388A (en) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090219509A1 (en) * | 2008-02-29 | 2009-09-03 | Hiroshi Nomura | Optical sensor with enhanced reflectance |
| US8008068B2 (en) * | 2008-02-29 | 2011-08-30 | Light Pointe Medical, Inc. | Nonhemolytic optical sensor with enhanced reflectance |
| CN102471796A (en) | 2009-07-27 | 2012-05-23 | 舒尔传感器有限公司 | Improvements relating to sensor devices |
| GB201007711D0 (en) | 2010-05-07 | 2010-06-23 | Pa Consulting Services | Devices and methods for testing analytes |
| CN102608107A (en) * | 2011-01-20 | 2012-07-25 | 中研应用感测科技股份有限公司 | Automatic test piece interpretation method and system |
| JP2012150096A (en) * | 2011-01-20 | 2012-08-09 | Middleland Sensing Technology Inc | Method and system for automatically determining test paper |
| US20130047415A1 (en) * | 2011-08-26 | 2013-02-28 | Lifescan Scotland Ltd. | Use of chamber height to affect calibration code in test strip manufacturing |
| US9063091B2 (en) | 2012-04-06 | 2015-06-23 | Ixensor Inc. | Test strips and method for reading test strips |
| US9778200B2 (en) * | 2012-12-18 | 2017-10-03 | Ixensor Co., Ltd. | Method and apparatus for analyte measurement |
| EP3578959A3 (en) * | 2013-01-07 | 2020-02-26 | Ixensor Co., Ltd. | Method for reading test strips |
| EP2781919A1 (en) | 2013-03-19 | 2014-09-24 | Roche Diagniostics GmbH | Method / device for generating a corrected value of an analyte concentration in a sample of a body fluid |
| KR101562946B1 (en) | 2013-04-23 | 2015-10-26 | 주식회사 수젠텍 | Devices and Methods for Detecting Analytes in Samples |
| FI126484B (en) | 2013-12-03 | 2017-01-13 | Goodwiller Oy | Disposable test strip device for detecting analyte in a body fluid sample |
| CN104062449B (en) * | 2014-07-02 | 2016-05-11 | 广州万孚生物技术股份有限公司 | Detection of electrons interpretation method and detection of electrons interpretation device |
| US20170184506A1 (en) * | 2015-12-29 | 2017-06-29 | Pritesh Arjunbhai Patel | Reagent test strips comprising reference regions for measurement with colorimetric test platform |
| KR20180004027A (en) * | 2016-06-30 | 2018-01-10 | 휴마시스 주식회사 | Analytical kit for enzyme activity |
| KR20180004028A (en) * | 2016-06-30 | 2018-01-10 | 휴마시스 주식회사 | Simultaneous analytical kit for diagnosis of disease using enzyme activity detection and immunological detection |
| CN109477837B (en) | 2016-09-28 | 2022-09-16 | 泰尔茂株式会社 | Method, composition and chip for detecting analyte in blood sample |
| CN112394184A (en) * | 2019-08-15 | 2021-02-23 | 保康特生物科技股份有限公司 | Detection system with identification tag compensation function |
| CN112394165A (en) * | 2019-08-16 | 2021-02-23 | 保康特生物科技股份有限公司 | Portable fast screening urine detection system with self-learning function |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5712170A (en) * | 1992-12-29 | 1998-01-27 | Oy Medix Biochemica Ab | Test strip, its production and use |
| US5843691A (en) * | 1993-05-15 | 1998-12-01 | Lifescan, Inc. | Visually-readable reagent test strip |
| EP1359417A2 (en) * | 2002-05-01 | 2003-11-05 | Lifescan, Inc. | Devices and methods for analyte concentration determination |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4900666A (en) | 1983-07-12 | 1990-02-13 | Lifescan, Inc. | Colorimetric ethanol analysis method and test device |
| US4649121A (en) * | 1985-02-26 | 1987-03-10 | Miles Laboratories, Inc. | Viability test device |
| US4935346A (en) | 1986-08-13 | 1990-06-19 | Lifescan, Inc. | Minimum procedure system for the determination of analytes |
| AU3375789A (en) * | 1988-04-28 | 1989-11-02 | Lifescan, Inc. | Determination of glucose in whole blood |
| DE3826922A1 (en) * | 1988-08-09 | 1990-02-22 | Boehringer Mannheim Gmbh | PROCESS FOR THE COLOR-RIMETRIC DETERMINATION OF AN ANALYTE BY ENZYMATIC OXIDATION |
| US5416000A (en) * | 1989-03-16 | 1995-05-16 | Chemtrak, Inc. | Analyte immunoassay in self-contained apparatus |
| US5268146A (en) * | 1992-03-25 | 1993-12-07 | Litmus Concepts, Inc. | Fast response test panel |
| GR1002549B (en) | 1992-05-12 | 1997-01-28 | Lifescan Inc. | Fluid conducting test strip with Transport Medium |
| WO1995013535A1 (en) * | 1993-11-12 | 1995-05-18 | Boehringer Mannheim Corporation | Glucose calibrator and control material for test strips |
| JP3843294B2 (en) * | 1996-09-11 | 2006-11-08 | アークレイ株式会社 | Test pieces |
| US6168957B1 (en) | 1997-06-25 | 2001-01-02 | Lifescan, Inc. | Diagnostic test strip having on-strip calibration |
| US6162397A (en) | 1998-08-13 | 2000-12-19 | Lifescan, Inc. | Visual blood glucose test strip |
| US5902731A (en) | 1998-09-28 | 1999-05-11 | Lifescan, Inc. | Diagnostics based on tetrazolium compounds |
-
2004
- 2004-07-30 US US10/903,108 patent/US20060024835A1/en not_active Abandoned
-
2005
- 2005-07-26 SG SG200504637A patent/SG119334A1/en unknown
- 2005-07-26 IL IL169893A patent/IL169893A0/en unknown
- 2005-07-27 AU AU2005203298A patent/AU2005203298A1/en not_active Abandoned
- 2005-07-29 CN CN2005100980570A patent/CN1737566B/en not_active Expired - Fee Related
- 2005-07-29 CA CA002514313A patent/CA2514313A1/en not_active Abandoned
- 2005-07-29 ES ES05254766T patent/ES2330759T3/en active Active
- 2005-07-29 KR KR1020050069678A patent/KR20060048959A/en not_active Application Discontinuation
- 2005-07-29 DE DE602005016347T patent/DE602005016347D1/en active Active
- 2005-07-29 AT AT05254766T patent/ATE441864T1/en not_active IP Right Cessation
- 2005-07-29 EP EP05254766A patent/EP1621887B1/en not_active Not-in-force
- 2005-07-29 TW TW094125687A patent/TW200617388A/en unknown
- 2005-07-29 JP JP2005221216A patent/JP2006071630A/en active Pending
-
2006
- 2006-05-30 HK HK06106279A patent/HK1086335A1/en not_active IP Right Cessation
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5712170A (en) * | 1992-12-29 | 1998-01-27 | Oy Medix Biochemica Ab | Test strip, its production and use |
| US5843691A (en) * | 1993-05-15 | 1998-12-01 | Lifescan, Inc. | Visually-readable reagent test strip |
| EP1359417A2 (en) * | 2002-05-01 | 2003-11-05 | Lifescan, Inc. | Devices and methods for analyte concentration determination |
Also Published As
| Publication number | Publication date |
|---|---|
| SG119334A1 (en) | 2006-02-28 |
| AU2005203298A1 (en) | 2006-02-16 |
| DE602005016347D1 (en) | 2009-10-15 |
| TW200617388A (en) | 2006-06-01 |
| EP1621887B1 (en) | 2009-09-02 |
| CA2514313A1 (en) | 2006-01-30 |
| HK1086335A1 (en) | 2006-09-15 |
| ATE441864T1 (en) | 2009-09-15 |
| JP2006071630A (en) | 2006-03-16 |
| CN1737566A (en) | 2006-02-22 |
| KR20060048959A (en) | 2006-05-18 |
| EP1621887A1 (en) | 2006-02-01 |
| IL169893A0 (en) | 2007-07-04 |
| US20060024835A1 (en) | 2006-02-02 |
| ES2330759T3 (en) | 2009-12-15 |
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